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PDA Technical Reports - Product Catalog - Parenteral Drug ...

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PDA Technical Reports - Product Catalog - Parenteral Drug ...

PDA Technical Reports No. TITLE Paper Version ... 20 Report on Survey of Current Industry Gowning Practices 1990 01020 41239 ... 25 Blend Uniformity Analysis: ...

https://store.pda.org/TableOfContents/PDA_Technical_Reports_list.pdf

Date added: October 8, 2012 - Views: 525

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PDA Journal of Pharmaceutical Science and Technology 2008 ...

Sterilizing Filtration of Liquids Technical Report No. 26 (Revised 2008) Supplement to the PDA Journal of Pharmaceutical Science and Technology

https://store.pda.org/TableOfContents/TR2608_TOC.pdf

Date added: December 9, 2012 - Views: 107

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Technical Report No. 48 Moist Heat Sterilizer Systems: Design ...

Moist Heat Sterilizer Systems: Design, Commissioning, Operation ... • PDA Technical Report No. 1, ... 25 Sterilizer Design ...

http://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/pda-technical-report-48-moist-heat-sterilizer-systems.pdf?sfvrsn=6

Date added: July 31, 2014 - Views: 2

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The Use of Stratified Sampling of Blend and Dosage Units to ...

statistical analysis such as the use of methods described in PDA Technical Report 254 should be ... Technical Report No. 25, ... The stratified sampling criteria ...

http://www.pqri.org/pdfs/DTC/Articles/Final_BUWG_Stratfied_Sampling.pdf

Date added: April 11, 2012 - Views: 26

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TECHNICAL REPORT NO. 36 - University of Arizona

technical report no. 36 mammals of the quitobaquito management area, organ pipe cactus national monument, arizona by ... 25 . iv figures and tables figures

http://sdfsnet.srnr.arizona.edu/data/techreports/TECHRPT36.pdf

Date added: October 8, 2012 - Views: 26

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PDA Draft Technical Report No. 29 - ..:: Pharmanet ...

PDA Technical Report No. 29 Points to Consider for Cleaning Validation DRAFT March 30, 1998 ... 25 Rinse Sampling..... 25 Coupon Sampling ...

http://www.pharmanet.com.br/pdf/tr29-002.pdf?origin=publication_detail

Date added: February 8, 2014 - Views: 20

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Cleaning Verification / Validation of Pharmaceutical ...

Cleaning Verification / Validation of Pharmaceutical Manufacturing ... • PDA Technical Report No. 29, ... Bioburden NMT 25 cfu per 25 cm2 – This level is

http://www.aaps.org/uploadedFiles/Content/Sections_and_Groups/Regional_Discussion_Groups/Southern_California_Pharmaceutical/Announcements/SC%20PDG%20Cleaning%20Verification%2019%20SEP%202013.pdf

Date added: October 30, 2013 - Views: 18

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PDA Technical Report 43 (Revised) - Parenteral Drug Association

Technical Report No. 43 (Revised) ... Genesis Technical Advisors NE PDA Meeting ... © 2013 Parenteral Drug Association 25 . Technical Report No. 43 ...

http://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/pda-technical-report-43-(revised).pdf?sfvrsn=6

Date added: September 5, 2014 - Views: 1

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Evaluation, Validation and Implementation of New ...

pda technical report no.33 evaluation, validation and implementation ... pda technical report no. 13, ... vol. 25, no. 5, ...

http://cdn2.hubspot.net/hub/54227/file-14538112-pdf/docs/tr33.pdf

Date added: November 22, 2013 - Views: 21

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Solid Oral Dosage Forms Powder Blending - İKEV

– Motion imparted by impeller as in Ribbon Blender ... • Parenteral Drug Association (PDA), Technical Report No. 25, “Blend Uniformity Analysis”, 1997.

http://www.ikev.org/haber/bozzonemay31.pdf

Date added: February 20, 2012 - Views: 31

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Qualification of temperature-controlled storage areas

5 PDA Technical Report No. 39: ... Refrigeration equipment maintenance 25 Performance qualification is normally carried out immediately after satisfactory

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-qualification-storage-areas-final-sign-off-a.pdf

Date added: June 5, 2014 - Views: 4

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Bioburden Biofilm Management Technical Report Update

PDA Technical Report on Bioburden and Biofilm ... develop visible colonies on R2A medium at 25 to 30oC ...

http://www.a.pda.org/docs/default-source/attendee-presentations/north-america/2014/2014-pda-annual-meeting/kalavati-suvarna-phd.pdf?sfvrsn=5

Date added: September 1, 2014 - Views: 3

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CIP Cycle Development and Cleaning Validation

PDA Technical Report #49 ... • Delta V Control Platform for all process and CIP skids (no PLC’s) ... / cycle = 25 hrs / month = 275 hr / year

http://www.ispe.org/great-lakes/2012cleaningvalidation.pdf

Date added: September 12, 2012 - Views: 133

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Meeting Summary PQRI Aseptic Processing Working Group ...

PDA Technical Report No. 13 (Revised), “Fundamentals of an Environmental Monitoring Program” Sept/Oct 2001. ... No 3 (25%) Page 17 of 19 March 4th, 2003 .

http://www.pqri.org/commworking/minutes/pdfs/mtc/apwg/022703min.pdf

Date added: April 3, 2012 - Views: 3

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USP Controlled Room Temperature Range Expansion - ...

temperature (25° or 30°) ... PDA Technical Report No. 53: Guidance for Industry: Stability Testing to Support Distribution of New Drug Products, 2011. 5:

http://www.thermosafe.com/blog/wp-content/uploads/2014/02/S20102.pdf

Date added: June 3, 2014 - Views: 3

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Monitoring isolator air - 800ezmicro - Microbiology International

As a PDA technical report states: ... for isolators: No interference with the normal usage of ... USP 25, Chapter 1116, ...

http://www.800ezmicro.com/component/docman/doc_download/266-monitoring-isolator-air.html

Date added: October 24, 2012 - Views: 28

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Temperature mapping of storage areas - World Health Organization

1 PDA Technical Report No. 39: ... specified temperature range +15°C to +25°C). A hot spot refers to the highest temperature value(s) ...

http://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-mapping-storage-areas-final-sign-off-a.pdf

Date added: June 8, 2014 - Views: 4

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Are We Setting Limits Correctly? Objections to current methods

Are We Setting Limits Correctly? Webinar: August 19, 2008 © 2008 Destin A. LeBlanc 5 25 Lilly approach and variants Fourman and Mullen paper PDA Technical Report No. 29

http://www.cleaningvalidation.com/risk-mapp-gate/2008%20August%20Webinar%20Limits%206%20per%20page.pdf

Date added: January 24, 2013 - Views: 8

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2014 PDA Europe Training Course Fundamentals of an ...

This course will focus on PDA Technical Report #13, Fundamentals of an Environmental Monitoring Program, ...

https://europe.pda.org/userfiles/downloads/2014_TC_EnvMonPro_flyer.pdf

Date added: November 22, 2014 - Views: 1

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Libero. New dimensions. The independent PDF Data Logger ...

... conform with PDA Technical Report No 39 ... Libero Sample Analysis Report . ... 25 to 40°C 2 days 8 to 25°C 6 days

http://www.nordealer.com/pdf-032008/Libero%20spec.%20tecniche.pdf

Date added: October 4, 2011 - Views: 7

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A New Vision - bioMerieux | In Vitro Diagnostics ...

... PDA Technical Report No. 36, ... PDA Journal of Pharmaceutical Science and ... after 8 days of incubation at 20-25°C on culture media from different ...

http://www.biomerieux-usa.com/upload/Media%20Fill%20Brochure-1.pdf

Date added: October 28, 2012 - Views: 12

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In this issue: p~LAL UPDATE® - Associates of Cape Cod, Inc.

changes in the newsletter. ... PDA Technical Report No.3, PDA, Philadelphia, PA). Three ... 25 0.5 Time (hr) 1.5 Oven Set at 300"C 300 250 200

http://www.acciusa.com/pdfs/newsletter/LAL_Vol.11No.5.pdf

Date added: March 14, 2012 - Views: 10

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Near-Infrared Spectroscopy and Imaging for the Monitoring of ...

PDA technical report No. 25.16 The PDA report No. 25 calls for all samples to be between 90 and 110% of the label claim and for the RSD to be <5%.

http://asrg.contactincontext.org/asrg/pdfs/powder_image.pdf

Date added: November 30, 2013 - Views: 7

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SporeNews MesaLabs - Mesa Labs Biological Indicators

Section 8.1 of PDA Technical Report No. 51 suggests that re-running the cycle ... Technical Report No. 51 Biological Indicators for Gas and Vapor ... 25, 101-121 ...

http://biologicalindicators.mesalabs.com/wp-content/uploads/sites/31/2014/03/Spore-News-Vol-9-No4.pdf

Date added: August 4, 2014 - Views: 1

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Process Validation: Solid Dosage Forms - :: สำนัก ...

Validation Final Report Outline Three Batches One Report No Pre-approval / No Photocopy: ... generating “Validation Report” for each ... PDA Technical Report # 25

http://drug.fda.moph.go.th/drug/zone_gmp/files/GMP2549_2/Aug2206/P2/PV_SDF_1_FDA.pdf

Date added: September 13, 2012 - Views: 93

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Applying a Knowledge-Based Approach to Pharmaceutical Supply ...

PDA Technical Reports 39, ... <30 °C <25 °C 8 to 25 °C 15 to 25 ... PDA Technical Report No. 53 Guidance for Industry:

http://www.interphex.com/RNA/RNA_Interphex_V2/documents/2012/speaker_presentations/ArmindaMontero.pdf?v=634722785190077147

Date added: March 31, 2014 - Views: 3

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2 Manuscript Title - ECVS INC

2 Manuscript Title: ... 13 This article describes a method for achieving the load equivalence model described in PDA Technical 14 Report 1 ... 25 minimizing time and ...

http://ecvs-inc.com/Library/Risk%20Based%20Approach%20to%20Variable%20Load%20Configuration%20Validation%20in%20Steam%20Sterilization_Final%20Manuscript%20for%20PDA.pdf

Date added: June 7, 2012 - Views: 17

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Libero. The Overview of the Models. - Bancolini

Marketing / AR LIBERO PDF Logger ... • -35° to -10°C as well as 25° to 70°C +/- 0.5°C for the ranges -35 to ... conform with PDA Technical Report No 39

http://www.bancolini.com/interne/brochure/LIBERO_TechSpecs_en.pdf

Date added: May 13, 2013 - Views: 2

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The Parenteral Drug Association presents 2013 PDA Europe ...

special group rate until 25 January 2013, Code: PDA. Reservation link: ... Finally, issues from the updated PDA Technical Report No. 33, RMM Validation, that is

http://www.tiselab.com/pdf/2013_Microbio_Brochure.pdf

Date added: November 13, 2013 - Views: 12

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Design of Experiments to Establish Temperature and Humidity ...

to Establish Temperature ... •PDA Technical Report No. 39, ... at 75% RH for 3 days, and the shelf life at 25 °C at 60 %RH must be

http://www.mbswonline.com/upload/presentation_5-24-2011-19-20-3.pdf

Date added: October 17, 2012 - Views: 6

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Case Study: Computer Supplier Evaluation Practices of the ...

the company had needed 25 people at each of its manufacturing sites. ... Audit Audit performed in accordance with PDA Technical Report No. 32

http://www.sei.cmu.edu/reports/03tr011.pdf

Date added: January 31, 2012 - Views: 14

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PDA Journal of Pharmaceutical Science and Technology

Vol. 53, No. 4 PDA Journal of ... The Code of Federal Regulations 211.25 under Personal ... Training Coordinators report to the TM.

http://www.gmptraining.com/uploads/A_Comprehensive_ApproachTo_Compliance_Training.pdf

Date added: June 24, 2013 - Views: 4

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Team LIBERO with internal sensors - Technical Specifications

-5 multiple alarm ranges, conform with PDA Technical Report No 39 (Cold ... +/-0.5° in the ranges of +25.1°..+200°C and -10.1°..-200°C

http://www.nordealer.com/index.php/component/k2/item/download/85_55a6991f01ee6b8032526aa61155b824

Date added: August 5, 2013 - Views: 9

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Technical Report 47 – “Creating a Research Database on ...

... TECHNICAL REPORT NO. 471 By Elizabeth A. Ruff, ... technical reports, ... Technical Report 47 –25 Thoughts Inventory (Sampson, ...

http://career.fsu.edu/documents/technical%20reports/Technical%20Report%2047/TR47.pdf

Date added: October 30, 2011 - Views: 48

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Cross-walk between EU Annex 11 and US FDA 211, 820, 11; other ...

820.25 11.10(i) EudraLex, ... PDA, Technical Report No. 32 Auditing of Supplier Providing Computer Products and Services for Regulated Pharmaceutical

http://www.computer-systems-validation.net/images/Regulatory_Analysis_rev_09-Jul-2014_.pdf

Date added: July 24, 2014 - Views: 1

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LIBERO: Innovation Leader in Cold Chain Monitoring

an open shipment report. Pre-configured LIBERO ... - Temperature accuracy of ± 0.2°C between -10°C..+25°C ... to PDA Technical Report No 39

http://www.elpro.com/uploads/tx_elproindustries/LIBERO_Innovation_Leader.pdf

Date added: February 5, 2014 - Views: 1

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Report # MATC-UI: 117 Final Report - Mid-America ...

Performing Organization Report No. 25 -1121 0003 117 9. ... The challenges that face autonomous vehicle are still significant. ... PDA personal digital assistant

http://matc.unl.edu/assets/documents/matcfinal/Schwarz_TowardsAutonomousVehicles.pdf

Date added: February 15, 2014 - Views: 2

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Transport route profiling qualification

7 PDA Technical Report No. 39: ... Determine the sampling size: ISTA recommends that at least 25 samples are applied for each variable. i.e., season ...

http://origin.who.int/entity/biologicals/expert_committee/Supplement-14-TS-route-profiling-final-ECSPP-ECBS.pdf

Date added: November 22, 2014 - Views: 1

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Autoclaves Qualification & Validation - Надлежащая ...

PDA Technical Reports • PDA Technical Report No. 1, ... 25 of 39 Autoclaves ... prolonged sterilisation run of empty autoclave after runs with

http://www.gmpua.com/Equipment/Sterility/Sterilization/QualificationofAutoclaves.pdf

Date added: October 19, 2011 - Views: 143

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Terminal Sterilization vs. Aseptic Processing

PDA Technical Report #36 : ... minimum dose of ≥25 KGy ? ... sterilization of a sealed container is validated to achieve the

http://forums.pharmacyonesource.com/phos/attachments/phos/pharmacy_ops/1377/1/terminal%20sterilization%20v%20aseptic.pdf

Date added: June 4, 2012 - Views: 95

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Training to Excellence - Nanyang Polytechnic

... [email protected] Training to Excellence ... and SIP processes such as those in PDA Technical Report No. 26, ... 25 May 2014 / 18 August 2014

http://www.nyp.edu.sg/pdc/display_file.cfm?file_name=NYP+-+Pall+Training+Brochure+2014.pdf&ff=Y

Date added: April 6, 2014 - Views: 12

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A Consensus Rating Method for Small Virus-Retentive Filters ...

final consensus filter method was published in the 2008 update of PDA Technical Report 41. Virus Filtration ... absolute for 20-nm to 25-nm viruses and that non-

http://www.mrzgroup.umd.edu/pdfs/2008_PDA_virus.pdf

Date added: April 3, 2014 - Views: 1

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Final Technical Report 26 May 1998—22 December 2001

Final Technical Report 26 May 1998—22 December 2001 National Renewable Energy Laboratory ... 90 25.28 -3.84 -4.96 12.98 -2.42 3.38 1.15 4.51 31.58

http://www.nrel.gov/docs/fy04osti/35092.pdf

Date added: May 21, 2013 - Views: 1

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A Novel Improved Bioburden Recovery Method Using Swabbing ...

A Novel Improved Bioburden Recovery Method Using Swabbing Technique ... (PDA) Technical Report No. 29,Points to ... Technical Report No. 29, ...

http://idosi.org/ijmr/ijmr3(3)12/9.pdf

Date added: March 20, 2013 - Views: 5

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Cleaning Validation with TOC - Insatech

Cleaning Validation with TOC ... Refer to PDA Technical Report 29 and 49 for further guidance 2. Key points: ... INSA 25 / 14 Summary

http://www.insatech.com/downloads/Cleaning_Validation_Jamie_Thompson_GE_Power___Water.pdf

Date added: April 1, 2014 - Views: 2

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PMF NEWSLETTER - The Microbiology Network | Dedicated to the ...

... (PDA Technical Report No. 51). The popu- ... Superheat < 25°C and Dryness >0.95. Change in Load Config-uration ... PMF Fall Forum - Advances in ...

http://www.microbiologyforum.org/content/file/PMFNews.17.05.1105.pdf

Date added: December 8, 2013 - Views: 1

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PDA Letter • February 2007 Science &amp; Technology Articles of ...

Science & Technology Articles of Interest to the Microbiologist ... preservatives tested were 0.25% ... PDA Technical Report # 28

http://www.microbiol.org/wp-content/uploads/2010/07/sutton.pda_letter.0702.pdf

Date added: March 9, 2012 - Views: 11

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PDA Forensic Tools - NIST Computer Security Division ...

PDA Forensic Tools: ... and technical analysis to advance the development and productive use of ... and the generated report from the script. 25.

http://csrc.nist.gov/publications/nistir/nistir-7100-PDAForensics.pdf

Date added: February 14, 2012 - Views: 40

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Temperature mapping of storage areas

3 PDA Technical Report No. 39: ... (e.g. hot spots identified between +23.0°C to +25.0°C in a room with a specified temperature range +15.0°C to +25.0°C).

http://origin.who.int/entity/biologicals/expert_committee/Supplement-8-TS-mapping-storage-areas-ECSPP-ECBS.pdf

Date added: November 22, 2014 - Views: 1